Impressive results from "game-changing" mRNA skin cancer vaccine trial
The first results from an advanced trial testing mRNA technology against cancer reveal 44% of patients fared better than those on conventional treatments alone. The preliminary announcement from Moderna reveals Phase 3 trials for its personalized mRNA skin cancer vaccine will commence next year.
Following the incredible success of mRNA COVID-19 vaccines in 2020, lots of work on the technology quickly shifted to explore its potential to treat cancer. Melanoma, in particular, turned out to be the first major cancer target for the technology, and both big mRNA companies (BioNTech and Moderna) are deep into Phase 2 human trials.
A new announcement from Moderna now offers the first data from any Phase 2 human trial testing mRNA technology for cancer. Moderna's mRNA skin cancer vaccine is dubbed mRNA-4157/V940, and it is personalized to each individual patient.
From a sample of a patient's melanoma, a personalized mRNA vaccine is created targeting up to 34 unique antigenic markers. The idea is that the vaccine helps train the immune system to target those specific tumor cells.
The ongoing Phase 2b trial has enrolled 157 patients with late-stage melanoma. Following surgery to remove as much of the skin cancer as possible, each patient was randomized to either receive standard cancer immunotherapy or the personalized mRNA vaccine plus standard immunotherapy. The primary endpoint of the trial is time between start of treatment to disease recurrence or death, with a follow-up period of three years.
The trial is ongoing, and no data has been formally published in a peer-reviewed journal. However, in a press release from Moderna, the preliminary results reveal treatment with the mRNA vaccine reduced a patient's risk of disease recurrence or death by 44% compared to those receiving standard immunotherapy alone.
"Today's results are highly encouraging for the field of cancer treatment," said Moderna CEO Stéphane Bancel. "mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma. We will begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualized cancer treatments to patients."
Andrew Beggs, a scientist working with Cancer Research UK, said mRNA cancer vaccines have important implications for metastatic cancer treatments in the future. Beggs, who did not work on Moderna's trial, said these kinds of personalized mRNA cancer therapies could be game changing if the results hold up in further tests.
“The use of the game-changing mRNA vaccine technology in increasing response to immunotherapy drugs is very exciting," said Beggs. "Although early data, it is very encouraging that this is a likely effective treatment option in the future."
While these results are the first to clinically demonstrate the efficacy of a mRNA treatment for cancer, there are likely more announcements coming soon. mRNA rival company BioNTech is deep into its own Phase 2 mRNA skin cancer vaccine trial, and it's likely we'll see preliminary data from that test in the not-too-distant future.
Moderna is racing forward with its work, currently mapping out a Phase 3 trial for its skin cancer vaccine, to commence in 2023, and exploring other cancer targets for the technology. Pharma giant Merck has also joined forces with Moderna to help manufacture and distribute the vaccine if final trials are successful.